Cryosurgical appliance

ABSTRACT

A cryosurgical appliance, particularly for use in the treatment of cysts or like fluid-containing formations. The appliance has a hollow body to contain fluid escaping from the formation, an opening in the body and a refrigeratory rim around the opening. The rim can be cooled and attached by gelation to the tissue to form a continuous seal around the point of penetration. On penetration of the tissue, any fluid escaping from the formation is contained within the hollow body of the appliance.

United States Patent I S aidi et a].

[s41 CRYOSURGICAL APPLIANCE [72] Inventors:

Farrokh Saidl, Shiraz, Iran; Alan John I Walker, Gi11ingham, England [73] Assignee:

Farrokh Saidi, Shiraz, Iran 221 Fi1ed: Mar. 9, 1910 211 App1.No.: 17,537

521 u. s.c|..... ..l28/303.l,62/293,128/400 511 mu... ..-A6lbl7/36 5s FieldofSearch ..12s/399-4o3,3o3.1,

[56 References Cited UNITED STATES PATENTS 3,391,690 7/1968 Armao ..128/2 3,067,589 12/1962 Dennis et a1 "62/293 3,353,531 11/1967 Armao t ..128/2 1,775,442 9/1930 Sarason ..128/403 X [4 1 Apr. 25, 1972 3,411,483 11/1968 Canoy ..128/303.1 X 3,266,492 8/1966 Steinberg.. ..128/303.1 3,483,869 12/1969 Hayhurst ..128/303.l 3,369,550 2/1968 Armao ..128/303.1 3,548,829 12/1970 Reynolds et a1. ..128/303.1

Primary Examiner-Richard A. Gaudet Assistant E.mminerl(y1e L. Howell A rforney-Lackenbach & Lackenbach [57] ABSTRACT I A cryosurgical appliance, particularly for use in the treatment of cysts or like fluid-containing formations. The appliance has a hollow body to contain fluid escaping from the formation, an opening in the body and a refrigeratory rim around the opening. The rim can be cooled and attached by gelation to the tissue to form a continuous seal around the point of penetration.

On penetration of the tissue, any fluid escaping from the formation is contained within the hollow body of the appliance.

16 Claims, 6 Drawing Figures PATENTEDAPR25|972 8,658,066

sum 1 OF 2 36%] "/0 j 2f L 1 19 16 I! v r mnnoxu sum ALAN JOHN mum: .7 mvzu'rons ATTORNEYS PATENTEDAPR 2 5 I972 SHEET 2 OF 2 www ATTORNEYS 1 CRYOSURGICAL APPLIANCE This invention relates to cryosurgical appliances. More particularly, it relates to such an appliance, for use in situations where body tissue is to be penetrated, which is adapted to allow penetration of the tissue while containing fluid which escapes therefrom.

The invention is particularly applicable to the treatment of cysts or other formations of the kind which are characterized by a thin sac or wall of such fragility, or in such a state of tension, as to make it difficult or even dangerous to perforate-or remove as a whole; or to situations such as localized abcesses where inadvertent rupture of the enclosing wall carries the risk of spillage of the contents to the surroundings in the process of evacuation.

Typical of the above-mentioned cysts is the hydatid cyst produced in the human body by. the parasitic wormechinococcus granulosis. In this condition the cystis composed of a thin and extremely fragile hyaline-type of membrane which ruptures on mild trauma of any kind, and leads to anuncontrolla ble escape of the cyst fluid. The cyst fluid contains viable scolices of the parasite which are capable of implanting into the surrounding tissues and in due course produce additional cysts. The condition produced is called secondary echinococcosis and is extremely difficult to handle with surgical or medical means. At times the contents of the cysts are degenerated material or bacterially affected, in which case spillage of these contents carries other risks as well.

The invention enables such cysts, or like formations presenting similar problems, to be completely or partially evacuated while minimizing or eliminating the risk of inadvertent spillage of its contents of whatever nature they maybe. The invention may also be used to insert substances in the cavity, for example for irrigation or washing out of the cavity. Additionally appliances may be introduced into the cavity, for example for inspection or appropriate management of the walls of the cavity. in all instances the mechanical isolation of the point of entry into the cyst or space permits safe handling ofits interior. 1

According to the present invention there is provided a cryosurgical appliance comprising a hollow body having an opening, a rim around the opening, and a conduit for fluid refrigerant arranged for cooling the rim so that the rim can be attached by gelation to the surface of the tissue whichis to be penetrated forming a continuous seal aroundthe point of penetration. The seal is formed by the gelation of body fluid already present, or of externally applied water or other liquid.

The rim is preferably made from materials, such as copper and silver, which have a high thermal conductivity. The rim is preferably hollow, the interior providing the conduit for fluid refrigerant, and has an inlet and outlet for the'refrigerant. The body may comprise an open-topped cup-like element with said opening and rim at its bottom. The appliance may include an inlet for the refrigerant fluid, and between the inlet and the rim-cooling conduit a Joule-Thomson expansion nozzle for cooling the fluid.

The appliance may further include a trocar for insertion through the opening to withdraw fluid from the cyst or cavity being treated. Alternatively the appliance may include a cryogenic probe for insertion through the aperture to freeze the contents of the cyst or other part being treated. Other instruments may also be used with the device, such as an in trascope for inspecting the interior'of the cyst or the like.

When the device is used for draining, as in the case of treating hydatid cysts, as the fluid escapes or is sucked out, the wall of the cyst collapses, and this may make it amenable to complete removal of the cyst membrane without the special risks previously attributable to its fragility.

The refrigerant may be a fluid which is supplied to the device at a temperature already low enough to affect gelation, for example a cooled or liquefied gas. Alternatively, a liquefied or pressurized gas at or around normal temperatures may be supplied to the device, the cooling effect being provided by a Joule-Thomson nozzle, which may be a separate unit in the fluid inlet line to the device, but preferably forms a part of the device itself. More than one such Joule-Thomson nozzle may be provided, directed at different parts of the rim so as to obtain more uniform cooling.

The invention will now be described by way of example only with reference to the accompanying drawings, wherein:

FIG. 1 shows a vertical cross-section through a first embodiment of appliance,

FIG. 2 shows a fragmentary cross-section on the line ll-II ofFIG. l,and

FIG. 3 shows across-section through a trocar for use'with the appliance,

FIG. 4 shows a diagrammatic cross-section of a second embodiment of the invention,

FIG. 5 shows a vertical cross-section a part of a modified fonn of the first embodiment,

FIG. 6 shows in vertical cross-section a suction device.

Referring firstly to FIGS. 1 and 2, the appliance comprises a frusto-conical cup-like hollowbody 10 made fromstainless steel sheet. The body is open at both ends; the smaller opening 12 at the bottom being surrounded by an annular rim 14 of copper brazed to the body 10. A brass tube 16 extends around the rim l4 and is brazed to it. The two ends 18, 19 of thetube 16 are led side by side upwardly from the rim (see FIG. 2).

modified form of Both the brass tubeand copper ring are silver-plated to ensure good thermal conductionand poor thermal radiation and absorption.

A stainless steel sleeve 20 extends down one side of the body 10 and is welded to it. The sleeve is closed at its. upper and lower ends by welded-in plugs 22, 24 respectively. The inlet 18 of the tube 16 extends into the lower plug 24 and is connected to a tube 26 which passes coaxially through both plugs 22, 24 and the sleeve 20. The outlet 19 from the tube 16 extends through the lower plug 24, opening into the sleeve 20.

Gas issuing from the outlet 19 can pass along the sleeve 20 and out through a passage 28 in theupper plug 22.

The upper'end 30 of the tube 26 projects'for the attachment of a supply pipe 32 for liquefied or pressurized gas. The upper end of the plug '28 has a rim '34 so that a flexible exhaust pipe 36 surrounding the supply pipe 32 can be push-fitted over the plug 28. Where the pipe 26 joins the inlet 18, it is provided with a Joule-Thomson nozzle 38, so that the gas or liquid passing along the tube 26 can expand through the nozzle into the inlet 18 and tube 16 which are at normal pressure. A stainless steel handle 40 is welded to the sleeve 20.

In use, in the treatment of hydatid cysts, the organ of the body containing the cyst is exposed and its portion overlying the cyst properly prepared surgically, or dissected off to expose the actual cyst membrane, as the situation demands. The exposed tissue is indicated notionally at 42 in FIG. I. The rim 14 of the appliance is placed in contact with the surface of the tissue, and liquefied or pressurized gas is passed down the supply pipe 32 and tube 26, so that it issues from the Joule- Thomson nozzle 38. The expansion causes the gas to cool so that it passes at low temperature around the tube 16 and out through the outlet 19, the sleeve 20, the passage 28, and exhaust pipe 36, to a suitable exhaust location. The cooled gas passing through the sleeve 20 lowers the temperature of the incoming gas in the tube 26, so that a cumulative cooling effect is quickly produced, and transmitted by conduction through the rim 14, which freezes to the tissueby gelation of t the body fluid present on the surface of the tissue, or of fluid applied to the surface. Freezing occurs to a small depth also within the tissue itself (indicated at 43 in FIG. 1), but usually this region should be kept fairly small so that it can be quickly thawed to allow removal ofthe appliance when desired. The

' Additional evacuation of the cyst can be effected by means of a trocar such as illustrated in FIG. 3. The trocar comprises a damage to the cyst wall when it is inserted into the cyst; The

branch 48 is connected to a suction pump (not shown); The

trocar is'held in the hand with a finger or thumb over the upper end 46. The end 48 isinserted into the cyst cavity with 1 the end 46 open. When it is suitably located, the duration and strength of the suction can be controlled by carefully using the finger to close or partially close the end 46. After drainage of the cyst, the rest of the cyst membrane can be extracted if desired; the attachment of the rim 14 to the cyst tissue can be useful in assisting this extraction. Finally, scolicidal agents may be introduced into the residual space. Once the cyst or similar'bodily cavities have been evacuated by the appliance, the flow of gas can be terminated and the point of attachment allowed to thaw, thus releasing the appliance from the tissue. The residual cavitycan be further dealt with in an appropriate manner; for example by irrigation, instillation of antibiotics, cauteri zation of the inside of the cavity, or simple suture obliteration. shutting Any suitable fluid which is gaseous at normal pressure and at operating temperatures may be used as the refrigerant; such as for example carbon dioxide or nitrous oxide. The Joule- Thomson cooling of pressurized fluid is preferred for this appliance in most cases because of its quick response to control, such as increasing or reducing or shutting off the flow of gas, for which purpose a flow control valve may be incorporated in the device or used separately therefrom. Ifa quick response of the control is not important; such as' would be the case where.

the entire cyst or the like is to be frozen, then a previously cooled fluid such as liquid nitrogen may be employed so as to produce a lower temperature and therefore faster freezing.

FIG. 4 shows diagrammatically in cross-section a modified form of appliance for use when the entire cyst is to be frozen.

The appliance comprises a cylindrical body part 50, having an opening 52 at one end and a portion 54 f reduced diameter at the other end. Extending through the portion 54 there is a probe member 56 which is coaxially slidable along the cylin- 1 drical part 50 through the opening'52. The body part 50 has an annular rim portion 58 at its open end 52, and a conduit 53 for fluid refrigerant for cooling the rim portion. The refrigerant may be a compressed gascooled by means of a Joule-Thomson nozzle in the conduit, in the manner prescribed for the first embodiment. Preferably however in this instance, since a much higher rate of cooling is required,

the refrigerant is a previously cooled fluid such as liquid nitrogen. The central probe 56 has a pointed nose'portion 60 which is also cooled by fluid refrigerant passing through a con duit 61 in the probe. The major freezing of the cyst tissue is to come from this probe, so that it will generally be necessary to use a previously cooled refrigerant in order to achieve the desired freezing in a reasonable time. Between the probe 56 and cylindrical body 50 is an annular space 62 which can receive any fluid escaping from the cyst before it is properly frozen. Where a previously cooled refrigerant is used, the main parts of the body 50 and probe 56 are either made from material having a poor thermal conductivity, or else they are provided with insulation so that the cooling effect of the refrigerant is not too much dissipated before reaching the rim and nose portions 58, 60 respectively. The rim and nose are made from material such as copper or silver which have a high thermal conductivity.

In use, the rim 58 is sealed to the cyst tissue by gelation in the manner previously described. Then the probe 56 is advanced so that its pointed end 60 .penetrates the cyst wall,

the annular space 62 is that cyst fluid escaping into this space allows the cyst to contract somewhat and separate from the normal surrounding tissue. This assists in insulating the cyst,

from the normal tissue and can be used to prevent or greatly reduce the freezing extending to the normal tissues.

In any embodiment of the invention which uses the Joule- Thomson effect to cool the pressurized refrigerant within the appliance, instead of using a single Joule-Thomson nozzle as shown in the first embodiment, a number of such nozzles can be used so as to more evenly distribute the cooling around the rim. For example, in the modification shown in FIG. 5, the rim 62 surrounding the opening 64 at the bottom of the frustoconical body 66 is in the form of. an annular tube, the hollow interior of which provides a conduit for the cooled fluid refrigerant. The refrigerant under pressure passes down a supply pipe 68 which extends in an annulus 69 aroundthe interior of the tubular rim 62. The annulus 69 is perforated at in tervals to provide nozzles through which the refrigerant fluid can escape and expand into the rim conduit 62.1An exhaust tube 70 leads from the conduit 62 concentrically around the supply pipe, 68.

The embodiment of suction device shown in FIG. 6 comprises an annular tube 72, provided with downwardly opening apertures 74, and a hollow stem 76 for connection to a suction pump. The stem can be branched as for the trocar shown in FIG. 3. The annular tube 72 can be fitted within the opening 12 of the cryosurgical appliance, and the trocar or other instrument can be-inserted through the annulus 72 into the cyst. This suction device enables fluid, which may enter the body 10 in large quantities, to be quickly evacuated.

Other modifications of design may be made without departing from the scope of this invention. The shape of the body in the first embodiment may be altered, for example by'in'voluting the upper rim of the body so as to allow greater tilting of the appliance without spillage of the liquid.

What we claim and desire to secure by' Letters Patent is: l. A cryosurgical appliance for treating fluid containing formations such as cysts by enabling penetration and draining thereof withoutcontamination of surrounding tissues by the draining fluid comprising a generally annular rim adapted for positioning and circling the point to bepenetrated, a conduit for fluid refrigerant extendingaround the rim, means for enabling a flow' of refrigerant fluid through said conduit for cooling and'sealing the rim by-gelation to the tissue surface completely around the point of penetration and a hollow body defined by wall means impervious to the fluids of such formation extending generally transversely outwardly of the plane of said rim for receiving and containing the draining fluid.

2. A cryosurgical appliance according to claim I, further .comprisinga supply pipe for supplying pressurized refrigerant fluid to said conduit and an expansion nozzle disposed between said supply pipe and said conduit for discharging the refrigerant fluid into the conduit and enabling adiabatic expansion of said fluid within said conduit to cool the rim.

3. A cryosurgical appliance according to claim 2 wherein the rim is hollow and defines the conduit, and the appliance v furthercomprises aninlet conduit extending through the holwhereupon refrigerant is passed so that the end 60 quickly exlow rim connected with said supply pipe and perforated at intervals to define a plurality of said expansion nozzles.

'4. A cryosurgical appliance according to claim 2 further comprising a refrigerant exhaust pipe leading from the conduit and surrounding the supply pipe so that the exhaust gas can cool the incoming pressurized fluid.

5. A cryosurgical appliance according to claim 1 further comprising, a cryogenic probe mounted; within the hollow body so as to be movable generally centrally perpendicularly past the rim and into the formation, and conduit means within the probe for supplying refrigerant to cool its leading end portion. t

6. A cryosurgicalapplian'ce according to claim '5 wherein the leading end of the probe is shaped for piercing the tissue.

7. A cryosurgical appliance according to claim 5 arranged to provide a space between the probe and the body to receive fluid escaping from the penetrated tissue.

8. A method of treatingcysts or the like fluid-containing formations by enabling penetration and draining thereof without'contamination of surrounding tissues by the draining fluid which comprises at least the steps of:

positioning a cryosurgical appliance comprising a hollow body, an opening in the body and a rim around the 'opening with such rim against the tissue surrounding the intended point of penetration, cooling such rim so as to form by gelation a continuous seal with such tissue around the point of intended penetration,

penetrating the tissue of such formation to allow fluid from the formation to escape and be contained by the hollow body, and

removing at least a part of such fluid.

9. A method according to claim 8 wherein said step of removing comprises, at least, the further step of:

removing by suction the fluid within thebody of the appliance and the remaining fluid in the formation.

10. A method according to claim 8 wherein said step of removing comprises, atleast, the steps of:

introducing a cryogenic probe into the interior of the formation, freezing at least part of the liquid remaining in the formation to form a frozen mass and removingthe frozen mass.

11. A cryosurgical appliance comprising a hollow body for containing body fluids having openings therein, a rim around one opening, means for conducting a refrigerant fluid along said rim to cool said rim and adapted for providing attachment thereof by gelation with body tissues forming a continuous seal along said rim and enabling piercing of the tissue exposed through said opening and collecting of fluids within said body drained through said pierced tissue.

12. Apparatus defined in claim 11 further comprising means for enabling removal of such fluids collected within said body without contamination of-the surrounding tissue.

13. Appliance defined in claim 11 wherein said refrigerant conducting means comprises a conduit extending along said rim, and a supply pipe for pressurized refrigerating fluid connected with said conduit. v

14. Appliance defined in claim 13 further comprising at least one expansion nozzle connected between said supply pipe and said conduit for discharging refrigerant fluid into said conduit and providing adiabatic expansion thereof to cool said nm.

15. Apparatus defined in claim 14 further comprising an inlet conduit extending coaxially within said. first-mentioned conduit, said supply pipe being connected with said inlet conduit and wherein said inlet pipe is perforated at intervals therealong to define a plurality of said expansion nozzles.

16. Apparatus defined in claim 15 wherein said rim is hollow and defines said first-mentioned conduit. 

1. A cryosurgical appliance for treating fluid-containing formations such as cysts by enabling penetration and draining thereof without contamination of surrounding tissues by the draining fluid comprising a generally annular rim adapted for positioning and circling the point to be penetrated, a conduit for fluid refrigerant extending around the rim, means for enabling a flow of refrigerant fluid through said conduit for cooling and sealing the rim by gelation to the tissue surface completely around the point of penetration and a hollow body defined by wall means impervious to the fluids of such formation extending generally transversely outwardly of the plane of said rim for receiving and containing the draining fluid.
 2. A cryosurgical appliance according to claim 1 further comprising a supply pipe for supplying pressurized refrigerant fluid to said conduit and an expansion nozzle disposed between said supply pipe and said conduit for discharging the refrigerant fluid into the conduit and enabling adiabatic expansion of said fluid within said conduit to cool the rim.
 3. A cryosurgical appliance according to claim 2 wherein the rim is hollow and defines the conduit, and the appliance further comprises an inlet conduit extending through the hollow rim connected with said supply pipe and perforated at intervals to define a plurality of said expansion nozzles.
 4. A cryosurgical appliance according to claim 2 further comprising a refrigerant exhaust pipe leading from the conduit and surrounding the supply pipe so that the exhaust gas can cool the incoming pressurized fluid.
 5. A cryosurgical appliance according to claim 1 further comprising, a cryogenic probe mounted within the hollow body so as to be movable generally centrally perpendicularly past the rim and into the formation, and conduit means within the probe for supplying refrigerant to cool its leading end portion.
 6. A cryosurgical appliance according to claim 5 wherein the leading end of the probe is shaped for piercing the tissue.
 7. A cryosurgical appliance according to claim 5 arranged to provide a space between the probe and the body to receive fluid escaping from the penetrated tissue.
 8. A method of treating cysts or the like fluid-containing formations by enabling penetration and draining thereof without contamination of surrounding tissues by the draining fluid which comprises at least the steps of: positioning a cryosurgical appliance comprising a hollow body, an opening in the body and a rim around the opening with such rim against the tissue surrounding the intended point of penetration, cooling such rim so as to form by gelation a continuous seal with such tissue around the point of intended penetration, penetrating the tissue of such formation to allow fluid from the formation to escape and be contained by the hollow body, and removing at least a part of such fluid.
 9. A method according to claim 8 wherein said step of removing comprises, at least, the further step of: removing by suction the fluid within the body of the appliance and the remaining fluid in the formation.
 10. A method according to claim 8 wherein said step of removing comprises, at least, the steps of: introducing a cryogenic probe into the interior of the formation, freezing at least part of the liquid remaining in the formation to form a frozen mass and removing the frozen mass.
 11. A cryosurgical appliance comprising a hollow body for containing body fluids having openings therein, a rim around one opening, means for conducting a refrigerant fluid along said rim to cool said rim and adapted for providing attachment thereof by gelation with body tissues forming a continuous seal along said rim and enabling piercing of the tissue exposed through Said opening and collecting of fluids within said body drained through said pierced tissue.
 12. Apparatus defined in claim 11 further comprising means for enabling removal of such fluids collected within said body without contamination of the surrounding tissue.
 13. Appliance defined in claim 11 wherein said refrigerant conducting means comprises a conduit extending along said rim, and a supply pipe for pressurized refrigerating fluid connected with said conduit.
 14. Appliance defined in claim 13 further comprising at least one expansion nozzle connected between said supply pipe and said conduit for discharging refrigerant fluid into said conduit and providing adiabatic expansion thereof to cool said rim.
 15. Apparatus defined in claim 14 further comprising an inlet conduit extending coaxially within said first-mentioned conduit, said supply pipe being connected with said inlet conduit and wherein said inlet pipe is perforated at intervals therealong to define a plurality of said expansion nozzles.
 16. Apparatus defined in claim 15 wherein said rim is hollow and defines said first-mentioned conduit. 